V-GRAD

V-GRAD is a sterile colloidal suspension containing silicate particles stabilized with hydrophilic silanes, used to separate motile sperm from ejaculates through density gradient centrifugation during assisted reproduction procedures. The device is available in three formulations: V-GRAD 100 (stock solution), V-GRAD 40, and V-GRAD 80 (ready-to-use solutions with HEPES-buffered Human Tubular Fluid), plus a V-GRAD Kit containing both the 40 and 80 variants.

V-GRAD differs from the predicate ORIGIO Gradient in gradient medium density (40%, 80%, 100% versus 40%, 80%, 90%, 100%), pH range (7.2–7.9 versus 7.95–8.495), endotoxin specification (<0.5 versus <0.8 EU/mL), and shelf-life (1 year versus 20–36 weeks). Both use aseptic filtration sterilization, have identical storage temperature (2–8°C), similar osmolality and density ranges, and demonstrate ≥80% human sperm survival at 24 hours post-exposure.

ISO 13408-1:2008 (Aseptic Processing Part 1), ISO 13408-2:2018 (Sterilizing Filtration), ASTM F1980-21 (shelf-life accelerated aging), ASTM D4169-22 (transportation testing), USP <71> (sterility), and USP <1207.2> (package integrity).

Although the devices differ in specific formulations, gradient densities, pH ranges, and shelf-life specifications, both share the identical intended use of sperm separation via density gradient methods and employ the same sterilization approach. The submission argues these differences do not raise different safety or effectiveness questions because performance testing—including shelf-life validation, sterility, endotoxin, osmolality, density, and Human Sperm Survival Assay data—demonstrates V-GRAD achieves comparable performance to the predicate and maintains product specifications through 12 months storage plus seven days post-opening use.